BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 5981741 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24196
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 6, 2016
    Report Date
    January 24, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED SELF-TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THE INSULIN PUMP PRIMED PROPERLY AND NO UNEXPECTED INSULIN FLOW BLOCKED ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED CASE, CASE CRACKED BEHIND THE PUMP NEAR THE BATTERY TUBE, SERIAL NUMBER LABEL FADED, PILLOWING KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO BE STUCK IN THE "PREPARING TO PRIME" LOOP. CUSTOMER REPORTED THAT INSULIN CONTINUED TO DRIP. CUSTOMER'S BLOOD GLUCOSE WAS 194 MG/DL. INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632738 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712B

    Patients

    Seq Age Sex Outcome Treatment
    1